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Diabetes em Movimento® - Community-based exercise program for people with type 2 diabetes

Condition category

Nutritional, Metabolic, Endocrine

Date applied

16/12/2012

Date assigned

28/12/2012

Last edited

10/12/2018

Prospective/Retrospective

Prospectively registered

Overall trial status

Completed

Recruitment status

No longer recruiting

Plain English Summary

Background and study aims Type 2 diabetes is a chronic disease that affects approximately 12.4% of Portuguese population and is associated with complications such as metabolic discontrol, diabetic foot, retinopathy (persistent or acute damage to the retina of the eye), nephropathy (damage to kidney), coronary artery disease and cerebrovascular disease. Exercise is widely recommended to control of type 2 diabetes and its complications. This study aims to: Determine the acute effects of different exercise types, intensities and durations in glycemic control and insulin resistanceDetermine the effects of a long term supervised exercise program in glycemic control, cardiovascular risk factors and physical fitness.

Who can participate? The Diabetes em Movimento® study aims to recruit about 60 individuals with diagnosed type 2 diabetes, from both genders, aged 55 or over, without major cardiovascular and orthopaedic disease and without gait and balance problems.

What does the study involve? Before participation, individuals will be evaluated at all variables analyzed in this study and a treadmill cardiovascular stress test. In the first phase of this study, 30 individuals (intervention group) will be submitted to exercise sessions of different types, intensities and durations. After this phase of acute effects, this group will participate in a long term (9 months) supervise exercise program. The control group (30 individuals) will be advised to continue normal living and not to engage in supervised exercise. All variables will be analyzed every 3 months.

What are the possible benefits and risks of participating? Participants can experience an immediate direct benefit from exercise sessions like reduced blood glucose levels and improved insulin sensitivity. Long term participation in a supervised exercise program can lead to a better glycemic control, reduced cardiovascular risk and improved physical fitness. The main risks are exercise-related adverse acute events like hypoglycaemia (low blood sugar), hyperglycemia (high blood sugar), angina pectoris (temporary chest discomfort that occurs when the heart is not getting enough blood), musculoskeletal injuries and dehydration. Proper planning of exercise sessions, and their monitoring by exercise professionals are crucial aspects to guarantee the safety of participants and to prevent this adverse events.

Where is the study run from? The Diabetes em Movimento® study has been set up by Research Center in Sports, Health Sciences and Human Development at the University of Trás-os-Montes and Alto Douro.

When is the study starting and how long is it expected to run for? Recruitment will start in January 2013. Participants will be enrolled in the study for a period of one year; however, the study will extend beyond this as we intend to evaluate participant's health over many months.

Who is funding the study? Funding has been provided by Portuguese Foundation for Science and Technology.

Study information

Scientific title

Acronym

Study hypothesis

It is hypothesized that different exercise types, intensities and durations have different acute effects on blood glucose and insulin resistance of type 2 diabetic patients.

It is also hypothesized that type 2 diabetic patients who engage in a supervised exercise program improve their glycemic control, cardiovascular risk factors and physical fitness in comparison with a control group without supervised exercise.

Protocol of the exercise program that we will used in this study: Mendes R, Sousa N, Reis VM, Themudo Barata JL. Programa de Exercício na Diabetes Tipo 2. Revista Portuguesa de Diabetes 2011;6(2):62-70.

Trial setting

Trial type

Patient information sheet

Condition

Intervention

In acute effects study, participants will be submitted to different exercise sessions (type, intensity and duration) in comparison to a control session of rest (crossover study).

In chronic effects study, participants will engage in a long term supervised exercise program (9 months), 3 sessions per week, 70 minutes duration. Exercise sessions will follow international recommendations for exercise in type 2 diabetes: aerobic, resistance, flexibility and agility exercise. Control group will continue normal living with no supervised exercise.

Secondary outcome measures

Overall trial start date

01/01/2013

Overall trial end date

31/12/2013

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 08/04/2013:1. Patients with diagnosed type 2 diabetes at least for three months2. Both genders3. Age ≥ 55 years4. Non-smokers5. Not engaged in supervised exercise6. Community-dwelling7. Medical recommendation for lifestyle intervention8. Known medical history9. Diabetes complications under medical control (metabolic discontrol, diabetic foot, diabetic retinopathy, diabetic nephropathy, diabetic autonomic neuropathy and cardiovascular risk)10. No cardiovascular, respiratory and musculoskeletal contraindications to exercise11. No gait and balance problems12. Not taking insulin for less than 3 months13. Volunteer participation with signed informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

Current exclusion criteria as of 08/04/2013:1. Participation in another supervised exercise program2. Changes in diabetes and cardiovascular medications3. Exercise adherence less than 65%4. Aggravation of diabetes complications or other major health problem

Funding Body Subtype

Location

Funder name

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Results and Publications

Publication and dissemination plan

1. To publish results from a pilot study and the final trial.2. To disseminate the trial among Portuguese and European societies in the scope of Diabetology, Endocrinology, Sports Medicine, General Practice and Public Health.3. To participate in national and international scientific events.